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Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

Developing clinical practice guidelines: target audiences, identifying topics for guidelines,... Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development. Background as the AHRQ Guideline Clearing House (www.guideline. Clinical practice guidelines (hereafter referred to as guide- gov)) that identify and systematically characterize guide- lines) are one of the foundations of efforts to improve lines on a number of domains and the development of health care. The modern age of guidelines began with a robust guideline appraisal instruments such as the 1992. Institute of Medicine report, which defined guide- AGREE tool [3,4] There has been the appearance of lines as “systematically developed statements to assist large scale guideline production organisations both at a practitioner and patient decisions about appropriate national level (such as the UK National Institute for health care forspecific clinical circumstances”.[1] In 1999, Health and Clinical Excellence or. Scottish Intercollegiate we authored a paper about methods to develop guidelines. Guidelines Network) and a condition level (such as the [2] It covered: identifying and refining the subject area of Ontario Cancer Guideline Program). There have also been the guideline; running guideline development groups; relevant reports (that some of us have participated in) for identifying and assessing the evidence; translating evi- the World Health Organisation [5]and professional soci- dence into a clinical practice guideline; and reviewing and eties (Schünemann HJ, Woodhead M, Anzueto A, Buist updating guidelines. Since it was published, the methods AS, MacNee W, Rabe KF, Heffner J. A guide for guidelines of guideline development have progressed both in terms for professional societies and other developers of recom- of methods and necessary procedures and the broad con- mendations: an official American Thoracic Society (ATS)/ text for clinical practice guidelines has changed. European Respiratory Society (ERS) Workshop Report; To help users identify and choose guidelines there has forthcoming). Such organizations and those interested in been the emergence of guideline clearing houses (such producing and using guidelines now have a high profile society in the Guidelines. International Network (http:// * Correspondence: shekelle@rand.org www.g-i-n.net/). Against this background it seems timely RAND Corporation, Santa Monica, CA 90407, USA 5 to, in a series of three articles, update and extend our earl- Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles ier paper on the methods of developing clinical practice CA 90073, USA Full list of author information is available at the end of the article © 2012 Eccles et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Eccles et al. Implementation Science 2012, 7:60 Page 2 of 8 http://www.implementationscience.com/content/7/1/60 guidelines. This series is based on a background paper [6] clinicians or social workers who work in primary care prepared for the Institute of Medicine report “Clinical settings. Even when the target audience is clearly physi- Practice Guidelines We Can Trust” [7]. cians, it is useful to clarify the type of physician(s) for In this first paper we discuss: the target audience(s) for whom the clinical practice guideline is primarily intended. guidelines and their use of guidelines; identifying topics Guidelines intended for primary care physicians may in- for guidelines; guideline group composition (including clude content of less interest to specialists, and vice versa. consumer involvement) and the processes by which Guidelines on a highly specialized procedure, performed guideline groups function and the important procedural only by sub-specialists, are unlikely to be used by primary issue of managing conflicts of interest in guideline devel- care physicians and therefore need not review basic back- opment. Inthe second paper we will move on to discuss ground on the health condition, can focus on narrow issues of identifying and synthesizing evidence: deciding evidence questions, and can use specialized terminology what type of evidence and outcomes to include in guide- without extensive elaboration. lines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, presenta- Prioritizing topics for guideline development tion of evidence; and moving from evidence to recom- There are many factors that influence the choice of mendations.Finally, in the third paper we will discuss the topics for the development of guidelines including scien- issues of: reviewing, reporting, and publishing guidelines; tific criteria set alongside the needs of health care policy- updating guidelines; and the two emerging issues of en- makers, specialty society professional identification, and hancing guideline implementability and how guideline in response to popular media coverage of certain high developers should approach dealing with the issue of profile cases. Guidelines can be developed around condi- patients who will be the subject of guidelines having co- tions (diabetes, hypertension, HIV infection, etc.) or morbid conditions. By updating our previous work we around procedures (coronary angiography, colonoscopy, hope to offer to a general reader a useful current over- carotid endarterectomy, etc.) The choice has to do with view of the main methodological and procedural issues the target audience and the need. Most guidelines are in guideline development. developed for conditions. Among the scientific factors are the criteria in Table 1. Target audiences and their use of guidelines Thus, situations for the development of guidelines are An important first step in developing a guideline is to often considered to be those conditions which are com- clarify the target audience. A clear sense of the target mon, costly, have large effects on premature mortality or audience informs subsequent decisions about the guide- morbidity, for which there is good evidence that appro- line’s scope, objectives, and format and style of wording. priate health care can make a difference in outcomes, Typically, guidelines have both primary and secondary and for which we know that there are wide variations in audiences. The primary audience is the category of clini- current care (as a proxy for professional uncertainty cians (and patients) for whom the guideline is nominally about how to care for the condition) or prima facie intended and who are most likely to use the guideline in knowledge that current care does not meet some well- patient care settings. However, guideline developers accepted standards. Clearly, judgment is needed in ap- often recognize a secondary audience that takes consid- plying these criteria. There are some conditions that are erable interest in the recommendations. For example, a rare, but for which receiving appropriate medical care is family medicine or paediatrics society may develop the difference between a normal health outcome and ca- guidelines for its practitioners, knowing that other pri- tastrophe (e.g. phenylketonuria). Such conditions should mary care professionals could refer to the guidelines in not be dismissed as a low priority for guidelines based managing the same condition. Guideline developers are solely on prevalence. Similarly, there are some condi- also aware that their recommendations may be used in tions which have only modest effects on morbidity, but policy processes such as informing coverage decisions by which are so common that the cumulative effects of ap- healthcare providers, insurers and employers’ benefits propriate management at a population level may be large packages. Guidelines often inadvertently focus on physicians as Table 1 Criteria for developing guidelines the target audience and use the term “physician” or � High prevalence condition or high use medical procedure “doctor” in lieu of “clinician,” but the topics they address � High associated cost may be equally relevant to a wider range of clinicians. � Effects on premature mortality and avoidable morbidity For example, a guideline on a primary care chronic dis- � Evidence that medical care can make a difference in outcomes ease management topic (such as diabetes mellitus) will � Knowledge of current variations in practice, or that practice does not be relevant not only to primary care physicians but also match some known practice parameters to nurse practitioners, physician assistants, and other Eccles et al. Implementation Science 2012, 7:60 Page 3 of 8 http://www.implementationscience.com/content/7/1/60 (e.g. acute pharyngitis). Also, the evidence that differ- compare with, these studies are usually interpreted to ences in clinical management lead to differences in support the use of multidisciplinary recommendation health care outcomes does not necessarily have to be groups. Lomas identified three reasons in support of this: positive - for some conditions, too much health care firstly, the limited information available for guideline de- might produce negative individual health or population velopment needs to be supplemented by the interpreta- outcomes (e.g. treating acute upper respiratory infec- tions of these stakeholders; secondly, legitimate conflicts tions with antibiotics may cause patients to have anti- over values need to be resolved; and thirdly, the successful biotic associated diarrhea or may increase community introduction of a guideline requires that all key disciplines antibiotic resistance rates). contribute to its development to ensure "ownership" and Most often the decisions about the relative importance support.[16] Given these empirical and theoretical argu- of prevalence, cost, effect of health care, etc., are made ments, there is a broad international consensus that implicitly; there is little published about how such deci- guideline development groups should be multidisciplinary sions are made. The US Preventive Services Task Force with representation from key stakeholder groups. (USPSTF) has a Topic Prioritization Workgroup that The number of group members and the balance of dis- regularly assesses nominations for guidelines that come ciplines should be influenced by the focus of the guide- from professional societies and other groups.[8] The lines. When deciding on the composition of the group, USPSTF does not use a formal scoring system, but ra- all potential stakeholders should be identified including: ther assesses each topic as a whole, using criteria similar health care professionals who are directly involved in the to that presented above, as do NICE and SIGN in the clinical management of patients in different health care UK. The American College of Physicians Clinical Guide- settings (for example, primary and secondary care), policy lines Group likewise uses a global judgment method for makers who may need to make decisions about resource prioritizing topics [9]. utilization and patients. There then has to be made a deci- sion about which categories of participant to involve Guideline group composition and group process within the guideline group. Guideline developers often Guideline development involves both a technical process have to weigh the desire for wide representation against (systematic reviews of relevant evidence) and a social the need for a cohesive working group. Small groups may process (interpretation of the results of the systematic not have sufficient experience within their members; lar- review and development of recommendations). The val- ger groups may lack cohesiveness and be difficult to lead. idity of guideline recommendations can be adversely In general, the optimum size for a small group is thought influenced if either process is biased. While there has to be between eight and ten people, although groups of been considerable methodological focus on ensuring the larger size have operated effectively. validity of the technical process, less attention has been paid to optimizing the social process.[10-14] The quality Consumer involvement in clinical practice guideline of the social process is dependent upon the composition development of the group (whether the right people have been brought There is an increasing (though still limited) literature on around the table) and the group process (whether the consumer involvement in health decision making in gen- process allows all to participate in a constructive discus- eral. A systematic review of patient and public involve- sion around the implications of the evidence). ment programs (PPIPs) in developing clinical practice guidelines [17] looked at stated reasons for including Group composition patients and the public within the process. Of 71 descrip- There is consistent empirical evidence that the compos- tive reports (guideline documents or methods reports, ition of recommendation making groups influence the evaluative studies) included in the review 23 reported resulting recommendations. Hutchings and colleagues using PPIPs to “incorporate patients’ values, preferences, completed a systematic review of factors affecting judg- knowledge, or perspectives in CPG recommendations”. ments produced by formal consensus development Other stated reasons were to “improve the implementa- methods.[15] They identified 22 studies that examined tion of the CPG (7/71), increase the comprehensiveness of the impact of specialty or profession of individual parti- the CPG (7/71), promote patients’ or the public’s influence cipants and observed that participants that performed a over the CPG development process (7/71), and adapt procedure were likely to rate more appropriate indica- CPGs to the target population (5/71)”. tions for that procedure. They also identified five studies These issues are reflected in the empirical work of that compared the recommendations made by uni- Boivin et al. [18] who, from 18 interviews with patients, disciplinary and multi-disciplinary groups; in all studies, health professionals, and public health experts, identified recommendations by multidisciplinary groups were four discourses about including patient preferences in the more conservative. While there is no gold standard to process of guideline development. Firstly a Governance Eccles et al. Implementation Science 2012, 7:60 Page 4 of 8 http://www.implementationscience.com/content/7/1/60 discourse (concerned with maximizing public health bene- with the use of technical language. Although they contribu- fits); secondly an Informed discourse (concerned with ted most in discussions of patient education, their contribu- maximizing consumer choice via information on benefits tions were not subsequently acted on. Within a ‘one off ’ and harms); thirdly a Professional Care discourse (con- meeting with a group of patients, participants again cerned with individualizing clinical decisions to individual encountered problems with medical terminology and were patients); and a Consumer Advocacy discourse (concerned most interested in sections on patient education and self with optimizing consumers political power within the management. Their understanding of the use of scientific process). The systematic review by Legare [17] represents evidence to derive more cost-effective care practices was the most comprehensive analysis of consumer involve- unclear. The workshop format was relative resource inten- ment to date though the literature is descriptive. Of the 71 sive but made it possible to explain the technical elements reports included only 28 were dealing with consumers of guideline development, enabling patients to engage in within the guideline development group itself and only 29 the process and make relevant suggestions. A patient ad- were dealing with consumers involved in crafting recom- vocate who served on a group felt confident to speak and mendations. Other methods of consumer involvement was accustomed to discussions with health professionals included workshops/meetings/seminars, involvement in and to medical terminology. systematic reviewing, focus groups, individual interviews However, the involvement of lay people in practice and public polls/surveys. Across the reports the authors guideline development can also be problematic. The identified a number of barriers to consumer involvement - North of England experiences and Legare’s review [17] the discrepancy between the views of patients and experts, demonstrated the challenges of the lack of consumers’ challenges of recruitment, obtaining representative input, training and scientific literacy (though this can apply in consumers lack of familiarity with technical issues and the degree to many other guideline group members). Another degree of work/time involved. Against these they set the challenge with consumer involvement occurs when the positive impact of training and support. representative has a visceral personal experience with the From the review it appears that there are still few ana- disease or an advocacy role that interferes with the ability lytical empirical accounts of attempts to involve consu- to examine the evidence and recommendations dispas- mers in guideline development, and there are no robust sionately. Such individuals may have difficulty divorcing evaluations of the effectiveness of different methods. A their personal narrative or policy agenda from the system- systematic review of the effectiveness of consumer in- atic methods and analytic rules a practice guideline group volvement in health decision making [19] only identified should follow. As a consequence, the group’s orderly re- six randomized controlled trials in total and did not find view of the evidence and construction of recommenda- any studies in the context of clinical guideline develop- tions can be sidelined by the objections and testimonials ment (despite searching). of the consumer representative. Williamson [20] has proposed three types of patient Several strategies exist for maximizing the benefits of representatives, depending on the contributions and consumer engagement while avoiding the difficulties. skills that each can bring: (a) fellow patients who would For example, as should occur with selecting any member mainly present their own views, (b) a member of a pa- of a practice guideline group, selection criteria can be tient group who presents the organization’s position, and applied in choosing a consumer representative with the (c) patient advocates who present knowledge of patient ability to consider the evidence objectively and make views. The North of England Evidence Based Guideline recommendations that depart from preconceived views Development Program described their experience of four or self interests. The National Institute for Health and methods of consumer involvement (three of which were Clinical Excellence in the United Kingdom advocates the based within the process of guideline development and involvement of at least two consumers on guideline de- one of which was conducted to explore the potential of velopment groups and provides induction sessions that the method for future use) [21]. They included: brief consumers on what to expect as participants. Another option is to not seat a consumer representa- incorporating individual patients in guideline tive on the guideline group itself, limiting the latter to development groups; professionals, but eliciting the perspective of patients a ‘one off ’ meeting with patients; and the public as part of a larger stakeholder input exer- a series of workshops with patients; cise. For example, a group may not include a consumer incorporating a consumer advocate in guideline representative but may invite patients or other layper- development groups sons to review draft documents or attend a group meet- ing to share their perspective. Guidelines groups can Individual patients who participated in a guideline devel- host an open forum, in which various stakeholder opment group contributed infrequently and had problems groups, such as patients, payers, manufacturers, and Eccles et al. Implementation Science 2012, 7:60 Page 5 of 8 http://www.implementationscience.com/content/7/1/60 professional associations, are afforded the opportunity to researchers than clinicians. During guideline develop- express their perspectives and criticisms, present scien- ment, the person(s) responsible for technical support tific evidence of relevance to the guideline, or raise con- should encourage the group to scrutinize the guideline cerns about the impact or implementation of proposed repeatedly to ensure its internal logic and clarity. recommendations [22]. The advantage of this approach is that it exposes the group’s deliberations to concerns Managing conflicts of interest in guideline development and information that it might otherwise overlook and What are conflicts of interest? provides stakeholders a sense of “being heard,” but it An aspect that has gained increasing prominence with leaves the group the freedom to then deliberate privately the “industrialisation” of guideline development is the in processing the comments. need to consider conflicts of interest. Financial, intellec- tual and other investments in aspects of health care can Guideline group processes result in biased judgement about a topic of interest; a A range of psychosocial factors can influence the progress concept that is generally called “conflict of interest”.A and content of group meetings.[10] Guideline development number of organizations have defined “conflicts of inter- groups undergo a socialization process (forming, storming, est” (COI) (Table 2). Grilli and co-workers evaluated 431 norming, performing, adjourning).[23] For example, during practice guidelines developed by specialty societies and the first few meetings of a group, much attention may be found that 67% did not report the type of professionals paid to the development of good interpersonal relations, involved in the guideline development.[26]. Therefore, an establishing group aims, developing norms of behavior and assessment of the potential influence of COI would not be exploring explicit and implicit roles. Such group-related possible. A study in the journal Nature of over 200 guide- issues may have to be addressed before substantial progress lines listed in the US National Guideline Clearinghouse can be made on the development of clinical recommenda- showed that half of the guidelines reported no information tions. Group decision-making essentially involves three regarding funding sources or financial conflicts of interest phases: orientation (defining the problem), evaluation (dis- of the authors [27]. cussion of decision alternatives), and control (deciding That COI can misinform healthcare decision makers is which of the alternatives is to prevail).[24] Ideal conditions widely recognized [30,31]. Omission of consideration for for group decision-making are those which enable the COI can damage an organization’s reputation or require views of all parties to be expressed and considered before a time consuming processes of dealing with perceived in- recommendation that is acceptable to the majority is fluence of COI. Examples include guidelines developed reached.[10] Dysfunctional group processes that allow un- by the World Health Organization, the surviving sepsis due influence of minority or majority views may result in campaign and the Infectious Disease Society of America the production of invalid or unreliable recommendations. Lyme Disease Guidelines [26,32-39]. Declaration and Examples include minority influence, group polarization management of COI is therefore of increasing importance and groupthink.[10] Multidisciplinary groups are particu- for medical professional societies and other organizations larly at risk in this regard, since their members vary in pro- developing practice guidelines [29,40,41]. Financial COI is fessional status, in the nature or depth of their specialist the best known type of COI and typically a result of direct knowledge and in their appreciation of the roles and modus financial benefit related to topics discussed or products operandi of their professional colleagues. recommended in guidelines. These personal financial The risk of such psychosocial biases can be reduced interests are not limited to employment, consultancies, with careful planning and attention to small group pro- paid expert 15 testimony, stock holdings, endowments, cesses. For example, it may be appropriate to ensure that patents, royalties, honoraria, and in kind gifts (e.g. travel, guideline development groups receive support to ensure accommodation, meals, frequent flier miles). Indirect that the group both functions effectively (the group process) and achieves its aims (the group task).[25] It is Table 2 Definitions of conflicts of interest possible for a single individual to be responsible for sup- A conflict of interest is a set of circumstances that creates a risk that porting both the group process and the group task. If a professional judgment or actions regarding a primary interest will be group is particularly large or if the task is particularly unduly influenced by a secondary interest.[28] (IoM) complex, however, such leadership roles may be better “A divergence between an individual’s private interests and his or her divided between two individuals, providing that both professional obligations such that an independent observer might they and the group are clear about their differing func- reasonably question whether the individual’s professional actions or decisions are motivated by personal gain, such as financial, academic tions. Technical support is required mainly to identify advancement, clinical revenue streams or community standing” [29] and synthesize evidence and present this to the group in “A financial or intellectual relationship that may impact an individual’s a form that allows them to make recommendations. This ability to approach a scientific question with an open mind” [29]. needs a range of skills more likely to be found within Eccles et al. Implementation Science 2012, 7:60 Page 6 of 8 http://www.implementationscience.com/content/7/1/60 financial interests are a reality as academic advancement How should guideline developers deal with conflict of can be related to topics discussed in guidelines. Direct interest? guideline funding by for-profit organizations is another Declaration of COI common problem and some authors have requested that Participants in guideline development should ideally sub- professional medical organizations reject all industry fund- mit written disclosures of all potential interests that may ing for practice guidelines [42]. cause a conflict of interest and disclosures should be made Intellectual COI is another type of conflict [29] that is prior to being involved in an official capacity. The individ- increasingly recognized and results from a guideline group ual can declare in writing: all known current and past member being invested in her/her intellectual work. Other interests relevant to the subject and scope of the matter examples include authorship of original studies and peer- for a number years prior to the date of declaration (many reviewed grant funding directly related to recommenda- organizations use a period of three years); and any con- tions under consideration. [29] Additional types of COI flicts of interest relevant to the subject and scope of the include academic conflicts (e.g. competition for funding) matter that are expected to occur in the near future. Dis- and conflicts related to clinical revenue streams (e.g., from closure can be made through standard forms or a uniform performing an advanced diagnostic procedure that is online process that could span across organizations. Up- under consideration for a recommendation). dating as individualcircumstances warrant, and attest to its accuracy and currency is important. All participants Why are conflicted individuals not categorically excluded (committee/group members and/or presenters) should be from guideline development? asked and reminded to consider their own conflicts and The biases resulting from COI may be conscious or uncon- conflicts of others during discussions and decision mak- scious [43] and may influence choices made throughout the ing. Participants should abstain from discussion and vot- guideline development process, including conceptualization ing if they or a sizable proportion of the other participants of the question, choice of comparisons, interpretation of identify a COI. The chair of the group should be free of the evidence and, in particular, drafting of the recommen- COI. dations.[44] Under these circumstances why are conflicted individuals not categorically excluded from guideline Review and management of COI development? Those choosing participants for guideline development The most knowledgeable individuals can be conflicted should review disclosures before deciding on partici- because of their expertise in the area of interest. These pants, and consider excluding participants if there is a “experts” may possess unique insight into appropriate non-resolvable conflict of interest. The procedures (in- healthcare questions to ask in guidelines. But because of cluding step by step review and management) is best their involvement in research they may have both finan- clearly described and part of a policy. This policy should cial and intellectual COIs whilst also possessing unique involve independent review of COI and decision making insight into aspects of the existing evidence such as by committees. Ideally guideline developers will provide study design and decisions made during conduct of stud- group members with examples of COI management ies. Such individuals may be difficult to replace because of from anonymous cases that describe appropriate meth- the unique insights they provide. The aim (and challenge) ods of COI management. should be to manage the potential COI appropriately ran- ging from informal consultation and exclusion from a Disclosure of COI to other group members group to participation without influencing recommenda- Once the members of a guideline group have been tions. Approaches to doing this have been described in a assembled, COI of members should be identified and dis- recent policy of the American Thoracic Society[29]; an ex- cussed before beginning deliberations. Individual partici- ample is in a WHO guideline on Avian Influenza where pants (including project chairs and group members) should un-conflicted methodologists prepared evidence summar- label where COI bear on specific recommendations. ies, chaired the guideline committee and wrote the first draft of the guideline.[45,46] A further implementation in- Recusal or excusal from certain decisions or cluding a clearer separation of un-conflicted methodolo- recommendations when appropriate gists from the influence of potentially conflicted experts is If groups involve members with (limited) COI, Chairs currently undertaken by the executive committee of the and group members on a guideline group should ensure American College of Chest Physicians Antithrombotic that committees are reminded of the specific COI before Guidelines.[47] In this latter approach un-conflicted discussion of individual conclusions or recommenda- methodologists lead the formulation of recommendations tions on which those COI bear. This will allow recusal in collaboration with experts who may be conflicted to a from recommendations of those with important COI. degree that would not preclude them from participation. Group chairs can play an active role and excuse group Eccles et al. Implementation Science 2012, 7:60 Page 7 of 8 http://www.implementationscience.com/content/7/1/60 members from discussions or decision-making on par- validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Quality and ticular recommendations. Safety in Health Care 2003, 12:18–23. 4. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers Procedures for handling disputes in COI resolution B, Graham ID, Grimshaw J, Hanna SE, et al: AGREE II: advancing guideline An organization should develop and oversee the proce- development, reporting and evaluation in health care. J Clin Epidemiol 2010, 63:1308–1311. dures and instruments used to disclose, review and resolve 5. Oxman AD, Fretheim A, Schünemann HJ: Improving the use of research COI, and should advise and assist chairs and organizers evidence in guideline development: introduction. Health Res Policy Syst where necessary. In instances where determination of COI 2006, 4:12. 6. Shekelle PG, Schunemann H, Woolf SH, Eccles M, Grimshaw J: State of the art and actions taken to resolve COI are disputed, procedures of CPG development and best practice standards.In Committee on should be in place to address the matter. Standards for Trustworthy Clinical Practice Guidelines commissioned paper.2010. [http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust. aspx] Summary 7. IOM (Institute of Medicine): Cinical Practice Guidelines We Can Trust.In Book In this first paper we have described target audiences for Cinical Practice Guidelines We Can Trust. 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Taylor R, Giles J: Cash interests taint drug advice. Nature 2005, 437:1070–1071. 28. Lo B, Fields M: Principles for Identifying and assessing conflicts of interest. Conflict of Interest in Medical Research, Education and Practice. In Book Principles for Identifying and assessing conflicts of interest. Conflict of Interest in Medical Research, Education and Practice. City: National Academies Press, Institute of Medicine; 2009:46. 29. Schunemann H, Osborne M, Moss J, Manthous C, Wagner G, Sicilian L, et al: An official American Thoracic Society Policy statement: managing conflict of interest in professional societies. Am J Respir Crit Care Med 2009, 180:564–580. 30. Als-Nielsen B, Chen W, Gluud C, Kjaergard LL: Association of funding and conclusions in randomized drug trials: a reflection of treatment effect or adverse events? JAMA 2003, 290:921–928. 31. Lexchin J, Bero LA, Djulbegovic B, Clark O: Pharmaceutical industry sponsorship and research outcome and quality: systematic review. 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Lantos PM, Charini WA, Medoff G, Moro MH, Mushatt DM, Parsonnet J, Sanders JW, Baker CJ: Final report of the Lyme disease review panel of the Infectious Diseases Society of America. Clin Infect Dis 2010, 51:1–5. 40. Boyd EA, Bero LA: Assessing faculty financial relationships with industry: A case study. JAMA 2000, 284:2209–2214. 41. Jacobs AK, Lindsay BD, Bellande BJ, Fonarow GC, Nishimura RA, Shah PM, Annex BH, Fuster V, Gibbons RJ, Jackson MJ, Rahimtoola SH: Task force 3: Disclosure of relationships with commercial interests: policy for educational activities and publications. J Am Coll Cardiol 2004, 44:1736–1740. 42. Rothman DJ, McDonald WJ, Berkowitz CD, Chimonas SC, DeAngelis CD, Hale RW, Nissen SE, Osborn JE, Scully JH Jr, Thomson GE, Wofsy D: Professional medical associations and their relationships with industry: a proposal for controlling conflict of interest. JAMA 2009, 301:1367–1372. 43. Dana J: Harm avoidance and financial conflict of interest. Journal of Medical Ethics 2003, Online Electronic Version: 1-18 44. Bero LA: Tobacco industry manipulation of research. Public Health Reps, March–April 2005, 120:200–208. 45. Schunemann HJ, Hill SR, Kakad M, Bellamy R, Uyeki TM, Hayden FG, Yazdanpanah Y, Beigel J, Chotpitayasunondh T, Del Mar C, et al: WHO Rapid Advice Guidelines for pharmacological management of sporadic human infection with avian influenza A (H5N1) virus. Lancet Infect Dis 2007, 7:21–31. Submit your next manuscript to BioMed Central 46. Schunemann HJ, Hill SR, Kakad M, Vist GE, Bellamy R, Stockman L, Wisloff TF, and take full advantage of: Del Mar C, Hayden F, Uyeki TM, et al: Transparent development of the WHO rapid advice guidelines. PLoS Med 2007, 4:e119. 47. Guyatt G, Akl EA, Hirsh J, Kearon C, Crowther M, Gutterman D, Lewis SZ, • Convenient online submission Nathanson I, Jaeschke R, Schunemann H: The vexing problem of • Thorough peer review guidelines and conflict of interest: a potential solution. Ann Intern Med • No space constraints or color figure charges 2010, 152:738–741. • Immediate publication on acceptance doi:10.1186/1748-5908-7-60 • Inclusion in PubMed, CAS, Scopus and Google Scholar Cite this article as: Eccles et al.: Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group • Research which is freely available for redistribution composition and functioning and conflicts of interest. Implementation Science 2012 7:60. Submit your manuscript at www.biomedcentral.com/submit http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Implementation Science Springer Journals

Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group composition and functioning and conflicts of interest

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Springer Journals
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Copyright © 2012 by Eccles et al.; licensee BioMed Central Ltd.
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Medicine & Public Health; Health Promotion and Disease Prevention; Health Administration; Health Informatics; Public Health
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Abstract

Clinical practice guidelines are one of the foundations of efforts to improve health care. In 1999, we authored a paper about methods to develop guidelines. Since it was published, the methods of guideline development have progressed both in terms of methods and necessary procedures and the context for guideline development has changed with the emergence of guideline clearing houses and large scale guideline production organisations (such as the UK National Institute for Health and Clinical Excellence). It therefore seems timely to, in a series of three articles, update and extend our earlier paper. In this first paper we discuss: the target audience(s) for guidelines and their use of guidelines; identifying topics for guidelines; guideline group composition (including consumer involvement) and the processes by which guideline groups function and the important procedural issue of managing conflicts of interest in guideline development. Background as the AHRQ Guideline Clearing House (www.guideline. Clinical practice guidelines (hereafter referred to as guide- gov)) that identify and systematically characterize guide- lines) are one of the foundations of efforts to improve lines on a number of domains and the development of health care. The modern age of guidelines began with a robust guideline appraisal instruments such as the 1992. Institute of Medicine report, which defined guide- AGREE tool [3,4] There has been the appearance of lines as “systematically developed statements to assist large scale guideline production organisations both at a practitioner and patient decisions about appropriate national level (such as the UK National Institute for health care forspecific clinical circumstances”.[1] In 1999, Health and Clinical Excellence or. Scottish Intercollegiate we authored a paper about methods to develop guidelines. Guidelines Network) and a condition level (such as the [2] It covered: identifying and refining the subject area of Ontario Cancer Guideline Program). There have also been the guideline; running guideline development groups; relevant reports (that some of us have participated in) for identifying and assessing the evidence; translating evi- the World Health Organisation [5]and professional soci- dence into a clinical practice guideline; and reviewing and eties (Schünemann HJ, Woodhead M, Anzueto A, Buist updating guidelines. Since it was published, the methods AS, MacNee W, Rabe KF, Heffner J. A guide for guidelines of guideline development have progressed both in terms for professional societies and other developers of recom- of methods and necessary procedures and the broad con- mendations: an official American Thoracic Society (ATS)/ text for clinical practice guidelines has changed. European Respiratory Society (ERS) Workshop Report; To help users identify and choose guidelines there has forthcoming). Such organizations and those interested in been the emergence of guideline clearing houses (such producing and using guidelines now have a high profile society in the Guidelines. International Network (http:// * Correspondence: shekelle@rand.org www.g-i-n.net/). Against this background it seems timely RAND Corporation, Santa Monica, CA 90407, USA 5 to, in a series of three articles, update and extend our earl- Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles ier paper on the methods of developing clinical practice CA 90073, USA Full list of author information is available at the end of the article © 2012 Eccles et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Eccles et al. Implementation Science 2012, 7:60 Page 2 of 8 http://www.implementationscience.com/content/7/1/60 guidelines. This series is based on a background paper [6] clinicians or social workers who work in primary care prepared for the Institute of Medicine report “Clinical settings. Even when the target audience is clearly physi- Practice Guidelines We Can Trust” [7]. cians, it is useful to clarify the type of physician(s) for In this first paper we discuss: the target audience(s) for whom the clinical practice guideline is primarily intended. guidelines and their use of guidelines; identifying topics Guidelines intended for primary care physicians may in- for guidelines; guideline group composition (including clude content of less interest to specialists, and vice versa. consumer involvement) and the processes by which Guidelines on a highly specialized procedure, performed guideline groups function and the important procedural only by sub-specialists, are unlikely to be used by primary issue of managing conflicts of interest in guideline devel- care physicians and therefore need not review basic back- opment. Inthe second paper we will move on to discuss ground on the health condition, can focus on narrow issues of identifying and synthesizing evidence: deciding evidence questions, and can use specialized terminology what type of evidence and outcomes to include in guide- without extensive elaboration. lines; integrating values into a guideline; incorporating economic considerations; synthesis, grading, presenta- Prioritizing topics for guideline development tion of evidence; and moving from evidence to recom- There are many factors that influence the choice of mendations.Finally, in the third paper we will discuss the topics for the development of guidelines including scien- issues of: reviewing, reporting, and publishing guidelines; tific criteria set alongside the needs of health care policy- updating guidelines; and the two emerging issues of en- makers, specialty society professional identification, and hancing guideline implementability and how guideline in response to popular media coverage of certain high developers should approach dealing with the issue of profile cases. Guidelines can be developed around condi- patients who will be the subject of guidelines having co- tions (diabetes, hypertension, HIV infection, etc.) or morbid conditions. By updating our previous work we around procedures (coronary angiography, colonoscopy, hope to offer to a general reader a useful current over- carotid endarterectomy, etc.) The choice has to do with view of the main methodological and procedural issues the target audience and the need. Most guidelines are in guideline development. developed for conditions. Among the scientific factors are the criteria in Table 1. Target audiences and their use of guidelines Thus, situations for the development of guidelines are An important first step in developing a guideline is to often considered to be those conditions which are com- clarify the target audience. A clear sense of the target mon, costly, have large effects on premature mortality or audience informs subsequent decisions about the guide- morbidity, for which there is good evidence that appro- line’s scope, objectives, and format and style of wording. priate health care can make a difference in outcomes, Typically, guidelines have both primary and secondary and for which we know that there are wide variations in audiences. The primary audience is the category of clini- current care (as a proxy for professional uncertainty cians (and patients) for whom the guideline is nominally about how to care for the condition) or prima facie intended and who are most likely to use the guideline in knowledge that current care does not meet some well- patient care settings. However, guideline developers accepted standards. Clearly, judgment is needed in ap- often recognize a secondary audience that takes consid- plying these criteria. There are some conditions that are erable interest in the recommendations. For example, a rare, but for which receiving appropriate medical care is family medicine or paediatrics society may develop the difference between a normal health outcome and ca- guidelines for its practitioners, knowing that other pri- tastrophe (e.g. phenylketonuria). Such conditions should mary care professionals could refer to the guidelines in not be dismissed as a low priority for guidelines based managing the same condition. Guideline developers are solely on prevalence. Similarly, there are some condi- also aware that their recommendations may be used in tions which have only modest effects on morbidity, but policy processes such as informing coverage decisions by which are so common that the cumulative effects of ap- healthcare providers, insurers and employers’ benefits propriate management at a population level may be large packages. Guidelines often inadvertently focus on physicians as Table 1 Criteria for developing guidelines the target audience and use the term “physician” or � High prevalence condition or high use medical procedure “doctor” in lieu of “clinician,” but the topics they address � High associated cost may be equally relevant to a wider range of clinicians. � Effects on premature mortality and avoidable morbidity For example, a guideline on a primary care chronic dis- � Evidence that medical care can make a difference in outcomes ease management topic (such as diabetes mellitus) will � Knowledge of current variations in practice, or that practice does not be relevant not only to primary care physicians but also match some known practice parameters to nurse practitioners, physician assistants, and other Eccles et al. Implementation Science 2012, 7:60 Page 3 of 8 http://www.implementationscience.com/content/7/1/60 (e.g. acute pharyngitis). Also, the evidence that differ- compare with, these studies are usually interpreted to ences in clinical management lead to differences in support the use of multidisciplinary recommendation health care outcomes does not necessarily have to be groups. Lomas identified three reasons in support of this: positive - for some conditions, too much health care firstly, the limited information available for guideline de- might produce negative individual health or population velopment needs to be supplemented by the interpreta- outcomes (e.g. treating acute upper respiratory infec- tions of these stakeholders; secondly, legitimate conflicts tions with antibiotics may cause patients to have anti- over values need to be resolved; and thirdly, the successful biotic associated diarrhea or may increase community introduction of a guideline requires that all key disciplines antibiotic resistance rates). contribute to its development to ensure "ownership" and Most often the decisions about the relative importance support.[16] Given these empirical and theoretical argu- of prevalence, cost, effect of health care, etc., are made ments, there is a broad international consensus that implicitly; there is little published about how such deci- guideline development groups should be multidisciplinary sions are made. The US Preventive Services Task Force with representation from key stakeholder groups. (USPSTF) has a Topic Prioritization Workgroup that The number of group members and the balance of dis- regularly assesses nominations for guidelines that come ciplines should be influenced by the focus of the guide- from professional societies and other groups.[8] The lines. When deciding on the composition of the group, USPSTF does not use a formal scoring system, but ra- all potential stakeholders should be identified including: ther assesses each topic as a whole, using criteria similar health care professionals who are directly involved in the to that presented above, as do NICE and SIGN in the clinical management of patients in different health care UK. The American College of Physicians Clinical Guide- settings (for example, primary and secondary care), policy lines Group likewise uses a global judgment method for makers who may need to make decisions about resource prioritizing topics [9]. utilization and patients. There then has to be made a deci- sion about which categories of participant to involve Guideline group composition and group process within the guideline group. Guideline developers often Guideline development involves both a technical process have to weigh the desire for wide representation against (systematic reviews of relevant evidence) and a social the need for a cohesive working group. Small groups may process (interpretation of the results of the systematic not have sufficient experience within their members; lar- review and development of recommendations). The val- ger groups may lack cohesiveness and be difficult to lead. idity of guideline recommendations can be adversely In general, the optimum size for a small group is thought influenced if either process is biased. While there has to be between eight and ten people, although groups of been considerable methodological focus on ensuring the larger size have operated effectively. validity of the technical process, less attention has been paid to optimizing the social process.[10-14] The quality Consumer involvement in clinical practice guideline of the social process is dependent upon the composition development of the group (whether the right people have been brought There is an increasing (though still limited) literature on around the table) and the group process (whether the consumer involvement in health decision making in gen- process allows all to participate in a constructive discus- eral. A systematic review of patient and public involve- sion around the implications of the evidence). ment programs (PPIPs) in developing clinical practice guidelines [17] looked at stated reasons for including Group composition patients and the public within the process. Of 71 descrip- There is consistent empirical evidence that the compos- tive reports (guideline documents or methods reports, ition of recommendation making groups influence the evaluative studies) included in the review 23 reported resulting recommendations. Hutchings and colleagues using PPIPs to “incorporate patients’ values, preferences, completed a systematic review of factors affecting judg- knowledge, or perspectives in CPG recommendations”. ments produced by formal consensus development Other stated reasons were to “improve the implementa- methods.[15] They identified 22 studies that examined tion of the CPG (7/71), increase the comprehensiveness of the impact of specialty or profession of individual parti- the CPG (7/71), promote patients’ or the public’s influence cipants and observed that participants that performed a over the CPG development process (7/71), and adapt procedure were likely to rate more appropriate indica- CPGs to the target population (5/71)”. tions for that procedure. They also identified five studies These issues are reflected in the empirical work of that compared the recommendations made by uni- Boivin et al. [18] who, from 18 interviews with patients, disciplinary and multi-disciplinary groups; in all studies, health professionals, and public health experts, identified recommendations by multidisciplinary groups were four discourses about including patient preferences in the more conservative. While there is no gold standard to process of guideline development. Firstly a Governance Eccles et al. Implementation Science 2012, 7:60 Page 4 of 8 http://www.implementationscience.com/content/7/1/60 discourse (concerned with maximizing public health bene- with the use of technical language. Although they contribu- fits); secondly an Informed discourse (concerned with ted most in discussions of patient education, their contribu- maximizing consumer choice via information on benefits tions were not subsequently acted on. Within a ‘one off ’ and harms); thirdly a Professional Care discourse (con- meeting with a group of patients, participants again cerned with individualizing clinical decisions to individual encountered problems with medical terminology and were patients); and a Consumer Advocacy discourse (concerned most interested in sections on patient education and self with optimizing consumers political power within the management. Their understanding of the use of scientific process). The systematic review by Legare [17] represents evidence to derive more cost-effective care practices was the most comprehensive analysis of consumer involve- unclear. The workshop format was relative resource inten- ment to date though the literature is descriptive. Of the 71 sive but made it possible to explain the technical elements reports included only 28 were dealing with consumers of guideline development, enabling patients to engage in within the guideline development group itself and only 29 the process and make relevant suggestions. A patient ad- were dealing with consumers involved in crafting recom- vocate who served on a group felt confident to speak and mendations. Other methods of consumer involvement was accustomed to discussions with health professionals included workshops/meetings/seminars, involvement in and to medical terminology. systematic reviewing, focus groups, individual interviews However, the involvement of lay people in practice and public polls/surveys. Across the reports the authors guideline development can also be problematic. The identified a number of barriers to consumer involvement - North of England experiences and Legare’s review [17] the discrepancy between the views of patients and experts, demonstrated the challenges of the lack of consumers’ challenges of recruitment, obtaining representative input, training and scientific literacy (though this can apply in consumers lack of familiarity with technical issues and the degree to many other guideline group members). Another degree of work/time involved. Against these they set the challenge with consumer involvement occurs when the positive impact of training and support. representative has a visceral personal experience with the From the review it appears that there are still few ana- disease or an advocacy role that interferes with the ability lytical empirical accounts of attempts to involve consu- to examine the evidence and recommendations dispas- mers in guideline development, and there are no robust sionately. Such individuals may have difficulty divorcing evaluations of the effectiveness of different methods. A their personal narrative or policy agenda from the system- systematic review of the effectiveness of consumer in- atic methods and analytic rules a practice guideline group volvement in health decision making [19] only identified should follow. As a consequence, the group’s orderly re- six randomized controlled trials in total and did not find view of the evidence and construction of recommenda- any studies in the context of clinical guideline develop- tions can be sidelined by the objections and testimonials ment (despite searching). of the consumer representative. Williamson [20] has proposed three types of patient Several strategies exist for maximizing the benefits of representatives, depending on the contributions and consumer engagement while avoiding the difficulties. skills that each can bring: (a) fellow patients who would For example, as should occur with selecting any member mainly present their own views, (b) a member of a pa- of a practice guideline group, selection criteria can be tient group who presents the organization’s position, and applied in choosing a consumer representative with the (c) patient advocates who present knowledge of patient ability to consider the evidence objectively and make views. The North of England Evidence Based Guideline recommendations that depart from preconceived views Development Program described their experience of four or self interests. The National Institute for Health and methods of consumer involvement (three of which were Clinical Excellence in the United Kingdom advocates the based within the process of guideline development and involvement of at least two consumers on guideline de- one of which was conducted to explore the potential of velopment groups and provides induction sessions that the method for future use) [21]. They included: brief consumers on what to expect as participants. Another option is to not seat a consumer representa- incorporating individual patients in guideline tive on the guideline group itself, limiting the latter to development groups; professionals, but eliciting the perspective of patients a ‘one off ’ meeting with patients; and the public as part of a larger stakeholder input exer- a series of workshops with patients; cise. For example, a group may not include a consumer incorporating a consumer advocate in guideline representative but may invite patients or other layper- development groups sons to review draft documents or attend a group meet- ing to share their perspective. Guidelines groups can Individual patients who participated in a guideline devel- host an open forum, in which various stakeholder opment group contributed infrequently and had problems groups, such as patients, payers, manufacturers, and Eccles et al. Implementation Science 2012, 7:60 Page 5 of 8 http://www.implementationscience.com/content/7/1/60 professional associations, are afforded the opportunity to researchers than clinicians. During guideline develop- express their perspectives and criticisms, present scien- ment, the person(s) responsible for technical support tific evidence of relevance to the guideline, or raise con- should encourage the group to scrutinize the guideline cerns about the impact or implementation of proposed repeatedly to ensure its internal logic and clarity. recommendations [22]. The advantage of this approach is that it exposes the group’s deliberations to concerns Managing conflicts of interest in guideline development and information that it might otherwise overlook and What are conflicts of interest? provides stakeholders a sense of “being heard,” but it An aspect that has gained increasing prominence with leaves the group the freedom to then deliberate privately the “industrialisation” of guideline development is the in processing the comments. need to consider conflicts of interest. Financial, intellec- tual and other investments in aspects of health care can Guideline group processes result in biased judgement about a topic of interest; a A range of psychosocial factors can influence the progress concept that is generally called “conflict of interest”.A and content of group meetings.[10] Guideline development number of organizations have defined “conflicts of inter- groups undergo a socialization process (forming, storming, est” (COI) (Table 2). Grilli and co-workers evaluated 431 norming, performing, adjourning).[23] For example, during practice guidelines developed by specialty societies and the first few meetings of a group, much attention may be found that 67% did not report the type of professionals paid to the development of good interpersonal relations, involved in the guideline development.[26]. Therefore, an establishing group aims, developing norms of behavior and assessment of the potential influence of COI would not be exploring explicit and implicit roles. Such group-related possible. A study in the journal Nature of over 200 guide- issues may have to be addressed before substantial progress lines listed in the US National Guideline Clearinghouse can be made on the development of clinical recommenda- showed that half of the guidelines reported no information tions. Group decision-making essentially involves three regarding funding sources or financial conflicts of interest phases: orientation (defining the problem), evaluation (dis- of the authors [27]. cussion of decision alternatives), and control (deciding That COI can misinform healthcare decision makers is which of the alternatives is to prevail).[24] Ideal conditions widely recognized [30,31]. Omission of consideration for for group decision-making are those which enable the COI can damage an organization’s reputation or require views of all parties to be expressed and considered before a time consuming processes of dealing with perceived in- recommendation that is acceptable to the majority is fluence of COI. Examples include guidelines developed reached.[10] Dysfunctional group processes that allow un- by the World Health Organization, the surviving sepsis due influence of minority or majority views may result in campaign and the Infectious Disease Society of America the production of invalid or unreliable recommendations. Lyme Disease Guidelines [26,32-39]. Declaration and Examples include minority influence, group polarization management of COI is therefore of increasing importance and groupthink.[10] Multidisciplinary groups are particu- for medical professional societies and other organizations larly at risk in this regard, since their members vary in pro- developing practice guidelines [29,40,41]. Financial COI is fessional status, in the nature or depth of their specialist the best known type of COI and typically a result of direct knowledge and in their appreciation of the roles and modus financial benefit related to topics discussed or products operandi of their professional colleagues. recommended in guidelines. These personal financial The risk of such psychosocial biases can be reduced interests are not limited to employment, consultancies, with careful planning and attention to small group pro- paid expert 15 testimony, stock holdings, endowments, cesses. For example, it may be appropriate to ensure that patents, royalties, honoraria, and in kind gifts (e.g. travel, guideline development groups receive support to ensure accommodation, meals, frequent flier miles). Indirect that the group both functions effectively (the group process) and achieves its aims (the group task).[25] It is Table 2 Definitions of conflicts of interest possible for a single individual to be responsible for sup- A conflict of interest is a set of circumstances that creates a risk that porting both the group process and the group task. If a professional judgment or actions regarding a primary interest will be group is particularly large or if the task is particularly unduly influenced by a secondary interest.[28] (IoM) complex, however, such leadership roles may be better “A divergence between an individual’s private interests and his or her divided between two individuals, providing that both professional obligations such that an independent observer might they and the group are clear about their differing func- reasonably question whether the individual’s professional actions or decisions are motivated by personal gain, such as financial, academic tions. Technical support is required mainly to identify advancement, clinical revenue streams or community standing” [29] and synthesize evidence and present this to the group in “A financial or intellectual relationship that may impact an individual’s a form that allows them to make recommendations. This ability to approach a scientific question with an open mind” [29]. needs a range of skills more likely to be found within Eccles et al. Implementation Science 2012, 7:60 Page 6 of 8 http://www.implementationscience.com/content/7/1/60 financial interests are a reality as academic advancement How should guideline developers deal with conflict of can be related to topics discussed in guidelines. Direct interest? guideline funding by for-profit organizations is another Declaration of COI common problem and some authors have requested that Participants in guideline development should ideally sub- professional medical organizations reject all industry fund- mit written disclosures of all potential interests that may ing for practice guidelines [42]. cause a conflict of interest and disclosures should be made Intellectual COI is another type of conflict [29] that is prior to being involved in an official capacity. The individ- increasingly recognized and results from a guideline group ual can declare in writing: all known current and past member being invested in her/her intellectual work. Other interests relevant to the subject and scope of the matter examples include authorship of original studies and peer- for a number years prior to the date of declaration (many reviewed grant funding directly related to recommenda- organizations use a period of three years); and any con- tions under consideration. [29] Additional types of COI flicts of interest relevant to the subject and scope of the include academic conflicts (e.g. competition for funding) matter that are expected to occur in the near future. Dis- and conflicts related to clinical revenue streams (e.g., from closure can be made through standard forms or a uniform performing an advanced diagnostic procedure that is online process that could span across organizations. Up- under consideration for a recommendation). dating as individualcircumstances warrant, and attest to its accuracy and currency is important. All participants Why are conflicted individuals not categorically excluded (committee/group members and/or presenters) should be from guideline development? asked and reminded to consider their own conflicts and The biases resulting from COI may be conscious or uncon- conflicts of others during discussions and decision mak- scious [43] and may influence choices made throughout the ing. Participants should abstain from discussion and vot- guideline development process, including conceptualization ing if they or a sizable proportion of the other participants of the question, choice of comparisons, interpretation of identify a COI. The chair of the group should be free of the evidence and, in particular, drafting of the recommen- COI. dations.[44] Under these circumstances why are conflicted individuals not categorically excluded from guideline Review and management of COI development? Those choosing participants for guideline development The most knowledgeable individuals can be conflicted should review disclosures before deciding on partici- because of their expertise in the area of interest. These pants, and consider excluding participants if there is a “experts” may possess unique insight into appropriate non-resolvable conflict of interest. The procedures (in- healthcare questions to ask in guidelines. But because of cluding step by step review and management) is best their involvement in research they may have both finan- clearly described and part of a policy. This policy should cial and intellectual COIs whilst also possessing unique involve independent review of COI and decision making insight into aspects of the existing evidence such as by committees. Ideally guideline developers will provide study design and decisions made during conduct of stud- group members with examples of COI management ies. Such individuals may be difficult to replace because of from anonymous cases that describe appropriate meth- the unique insights they provide. The aim (and challenge) ods of COI management. should be to manage the potential COI appropriately ran- ging from informal consultation and exclusion from a Disclosure of COI to other group members group to participation without influencing recommenda- Once the members of a guideline group have been tions. Approaches to doing this have been described in a assembled, COI of members should be identified and dis- recent policy of the American Thoracic Society[29]; an ex- cussed before beginning deliberations. Individual partici- ample is in a WHO guideline on Avian Influenza where pants (including project chairs and group members) should un-conflicted methodologists prepared evidence summar- label where COI bear on specific recommendations. ies, chaired the guideline committee and wrote the first draft of the guideline.[45,46] A further implementation in- Recusal or excusal from certain decisions or cluding a clearer separation of un-conflicted methodolo- recommendations when appropriate gists from the influence of potentially conflicted experts is If groups involve members with (limited) COI, Chairs currently undertaken by the executive committee of the and group members on a guideline group should ensure American College of Chest Physicians Antithrombotic that committees are reminded of the specific COI before Guidelines.[47] In this latter approach un-conflicted discussion of individual conclusions or recommenda- methodologists lead the formulation of recommendations tions on which those COI bear. This will allow recusal in collaboration with experts who may be conflicted to a from recommendations of those with important COI. degree that would not preclude them from participation. Group chairs can play an active role and excuse group Eccles et al. Implementation Science 2012, 7:60 Page 7 of 8 http://www.implementationscience.com/content/7/1/60 members from discussions or decision-making on par- validation of an international appraisal instrument for assessing the quality of clinical practice guidelines: the AGREE project. Quality and ticular recommendations. Safety in Health Care 2003, 12:18–23. 4. Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers Procedures for handling disputes in COI resolution B, Graham ID, Grimshaw J, Hanna SE, et al: AGREE II: advancing guideline An organization should develop and oversee the proce- development, reporting and evaluation in health care. J Clin Epidemiol 2010, 63:1308–1311. dures and instruments used to disclose, review and resolve 5. Oxman AD, Fretheim A, Schünemann HJ: Improving the use of research COI, and should advise and assist chairs and organizers evidence in guideline development: introduction. Health Res Policy Syst where necessary. In instances where determination of COI 2006, 4:12. 6. Shekelle PG, Schunemann H, Woolf SH, Eccles M, Grimshaw J: State of the art and actions taken to resolve COI are disputed, procedures of CPG development and best practice standards.In Committee on should be in place to address the matter. Standards for Trustworthy Clinical Practice Guidelines commissioned paper.2010. [http://www.iom.edu/Reports/2011/Clinical-Practice-Guidelines-We-Can-Trust. aspx] Summary 7. IOM (Institute of Medicine): Cinical Practice Guidelines We Can Trust.In Book In this first paper we have described target audiences for Cinical Practice Guidelines We Can Trust. City: The National Academies Press; 2011. guidelines, the criteria for choosing topics for guideline de- 8. U.S. Preventive Services Task Force: Section 2: Topic Selection, Prioritization, and Updating. [http://www.uspreventiveservicestaskforce.org/uspstf08/ velopment (including acknowledging the current debate methods/procmanual2.htm] about co-morbidities), group composition and group pro- 9. Qaseem A, Snow V, Owen DK, Shekelle PG: The development of clinical cesses and the important procedural issue of managing con- practice guidelines and guidance statements of the American College of Physicians: summary of methods. Ann Intern Med 2010, 153:194–199. flicts of interest. In the next paper we move on to discuss 10. Pagliari C, Grimshaw J, Eccles M: The potential influence of small group issues of identifying and synthesizing evidence: deciding processes on guideline development. J Eval Clin Pract 2001, 7:165–173. what type of evidence and outcomes to include in guide- 11. Pagliari C, Grimshaw J: Impact of group structure and process on multidisciplinary evidence-based guideline development: an lines; integrating values into a guideline; incorporating eco- observational study. J Eval Clin Pract 2002, 8:145–153. nomic considerations; synthesis, grading, presentation of 12. Moreira T, May C, Mason J, Eccles M: A new method of analysis enabled a evidence; and moving from evidence to recommendations. better understanding of clinical practice guideline development processes. J Clin Epidemiol 2006, 59:1199–1206. Competing interests 13. Moreira T: Diversity in clinical guidelines: the role of repertoires of MPE is Editor in Chief of Implementation Science; Jeremy Grimshaw is an evaluation. Soc Sci Med 2005, 60:1975–1985. Editorial Board member. All decisions on this paper were made by another 14. Gardner B, Davidson R, McAteer J, Michie S: A method for studying decision- editor. 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Ann Intern Med • No space constraints or color figure charges 2010, 152:738–741. • Immediate publication on acceptance doi:10.1186/1748-5908-7-60 • Inclusion in PubMed, CAS, Scopus and Google Scholar Cite this article as: Eccles et al.: Developing clinical practice guidelines: target audiences, identifying topics for guidelines, guideline group • Research which is freely available for redistribution composition and functioning and conflicts of interest. Implementation Science 2012 7:60. Submit your manuscript at www.biomedcentral.com/submit

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